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References

  1. Increlex® [package insert]. Brisbane, CA: Tercica, Inc.; 2005.
  2. Rogol AD, Clark PA, Roemmich JN. Growth and pubertal development in children and adolescents: effects of diet and physical activity. Am J Clin Nutr. 2000;72(suppl):521S-8S.
  3. Rosenfeld RG, Cohen P. Disorders of growth hormone/insulin-like growth factor secretion and action. In: Sperling MA, ed. Pediatric Endocrinology. 3rd ed. Philadelphia, PA: Saunders Elsevier; 2008:281-8.
  4. Edouard, T, Grunenwald, S, Gennero, I, Salles, J P, Tauber, M. Prevalence of IGF1 deficiency in prepubertal children with isolated short stature. Eur J Endocrinol. 2009;161: 43-50.
  5. Marieb EN. Human Anatomy and Physiology. 5th ed. San Francisco, CA: Benjamin Cummings; 2001:609.
  6. Ranke, MB. Defining insulin-like growth factor-1 deficiency. Horm Res. 2006;65(suppl 1):9-14.
  7. Chernausek SD, Backelijauw PF, Frane J, Kuntze J, Underwood LE; for the GH Insensitivity Syndrome Collaborative Group. Long-term treatment with recombinant insulin-like growth factor (IGF)-1 in children with severe primary IGF-1 deficiency due to growth hormone insensitivity. J Clin Endocrinol Metab. 2007;92(3):902-910.
  8. Bakker B, Frane J, Anhalt H, Lippe B, Rosenfeld RG. Height velocity targets from the national cooperative growth study for first-year growth hormone responses in short children. J Clin Endocrinol Metab. 2008;93:352-357.
  9. Fintini D, Brufani C, Cappa M. Profile of mecasermin for the long-term treatment of growth failure in children and adolescents with severe Primary IGF-1 deficiency. Ther Clin Risk Manage. 2009; 5(3):553-559.
  10. Ranke MB. Diagnosis of growth hormone deficiency and growth hormone stimulation tests. In: Ranke MB, ed. Diagnostics of Endocrine Function in Children and Adolescents. Basel: S. Karger AG; 2003: 107-128.
  11. Ranke MB, Feldt-Rasmussen U, Bang P, et al. How should IGF-I be measured? A consensus statement. Horm Res. 2001;55(suppl 2):106-109.
  12. Moseley CT, Phillips, JA. Pituitary gene mutations and the growth hormone pathway. Semin Reprod Med. 2000; 18(1):21-29. Accessed by Medscape. http://www.medscape.com/viewarticle/410889_print
  13. Rosenfeld, RG. Pharmacogenomics of pharmacoproteonics in the evaluation and management of short stature. Eur J Endocrinol. 2007; 157(suppl):S27-S31.
  14. Rosenfeld RG. Molecular mechanisms of IGF-1 deficiency. Horm Res. 2006; 65 (suppl 1):15-20.
  15. Rosenfeld RG. Biochemical diagnostic strategies in the evaluation of short stature: the diagnosis of insulin-like growth factor deficiency. Horm Res. 1996; 46:170-173.
  16. Rosenfeld RG, Rosenbloom AL, Guevara-Aguirre J. Growth hormone (GH) insensitivity due to primary GH receptor deficiency. Endocr Rev. 1994; 15 (3):369-390.
  17. Bercu, B. Treatment, dosing, and follow-up of children with primary and secondary IGFD. Rev Endocrinol. July 2008: 38-40.
  18. Park, P, Cohen, P. Insulin-like growth factor 1 (IGF-1) measurements in growth hormone (GH) therapy of idiopathic short stature (ISS). Growth Horm IGF Res. 2005;15 (supplA):S13-20.
  19. Clayton PE, Ayoola O, Whatmore AJ. Patient selection for IGF-I therapy. Horm Res. 2006;65(suppl 1):28-34.
  20. Rosenthal S, Cohen P, Clayton P, et al. Part II: Defining and managing growth hormone treatment failure. Pediatr Endocrinol Rev. 2007; 4 (suppl 2): 257-268.
  21. Rosenthal, S, Cohen P, Clayton, P Backeljauw P, Bang P, Ten S. Treatment perspectives in idiopathic short stature with a focus on IGF-1 deficiency. Pediatr Endocrinol Rev. 2007; 4 (suppl 2):252-271.
  22. Cohen P, Rogol AD, Deal CL, et al. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008;93(11):4210-4217.
  23. Wit JM, Clayton PE, Rogol AD, Savage MO, Saenger PH, Cohen P. Idiopathic short stature: definition, epidemiology, and diagnostic evaluation. Growth Horm IGF Res. 2008;18(2):89-110.
  24. Savage, MO, Blair, JC, Jorge, AJ, Street, ME, Ranke, MB, Camacho-Hübner C. IGFs and IGFBPs in GH insensitivity. In: Cianfarani S, Clemmons DR, Savage MO, eds. IGF-I and IGF Binding Proteins. Basic Research and Clinical Management: Endocrine Development. Basel: S. Karger AG; 2005:100-106.
  25. American Association for Clinical Chemistry. IGF-1: The Test. LabTestsOnline Web site. http://www.labtestsonline.org/understanding/analytes/igf1/test.html. Accessed August 9, 2010.
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  29. Reiner B, Bowlby D, Kuntze J, Hertz J, Frane JW, Blethen S. Increlex therapy in children who were treatment-naïve or previously treated with growth-promoting therapy: first-year results from the Increlex Growth Forum Database (IGFD) registry. Poster presented at: ENDO 2010: 92nd Annual Meeting and Expo; June 20, 2010; San Diego, CA.
  30. Backeljauw PF, Underwood LE. Therapy for 6.5-7.5 years with recombinant insulin-like growth factor I in children with growth hormone insensitivity syndrome: a clinical research center study. J Clin Endocrinol Metab. 2001; 86(4):1504-1510.
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  34. Data on file. Brisbane, CA: Tercica, Inc.; 2010.
  35. Increlex® [Patient package insert]. Brisbane, CA: Tercica, Inc.; 2005.

Indication and Important Safety Information

Who is Increlex® for?
INCRELEX is used to treat children who are very short for their age because their bodies do not make enough IGF-1. This condition is called severe primary IGF-1 deficiency. INCRELEX should not be used instead of growth hormone.

Who should not use Increlex?
Your child should not take INCRELEX if your child: has finished growing (the growth plates at the end of the bones are closed); has cancer; has other causes of growth failure; OR is allergic to mecasermin or any of the inactive ingredients in INCRELEX. INCRELEX has not been studied in children under 2 years of age and should never be used in newborns. Your child should never receive INCRELEX through a vein.

Before your child takes Increlex, you should tell your child's doctor about:
All of your child's health conditions, including: diabetes, kidney problems, liver problems, allergies, scoliosis (curved spine), pregnancy, or breast-feeding.

All the medicines (prescription and nonprescription), vitamins, and herbal supplements your child takes, especially insulin or other anti-diabetes medicines, which may require dose adjustment of these medicines.

What are possible side effects of increlex (some of which can be serious)?
Low blood sugar (hypoglycemia). Only give your child INCRELEX right before or right after (20 minutes on either side of) a snack or meal to reduce the chances of hypoglycemia. Signs include dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, and fast or irregular heartbeat. Do not give your child INCRELEX if your child is sick or cannot eat.

Severe hypoglycemia may cause unconsciousness, seizures, or death. People taking INCRELEX should avoid participating in high risk activities (such as driving) within 2 to 3 hours after an INCRELEX injection.

Increased pressure in the brain (intracranial hypertension). INCRELEX, like growth hormone, can sometimes cause a temporary increase in pressure within the brain. Symptoms include persistent headache, blurred vision, and nausea with vomiting.

Allergic reactions. Your child may have a mild or serious allergic reaction with Increlex. Call your child's doctor right away if your child gets a rash or hives. Hives, also known as urticaria, appear as a raised, itchy skin reaction. Hives appear pale in the middle with a red rim around them. Hives generally appear minutes to hours after the injection and may sometimes occur at numerous places on the skin. Get medical help immediately if your child has trouble breathing or goes into shock, with symptoms like dizziness, pale, clammy skin, and/or passing out.

Enlarged tonsils. Signs include: snoring, difficulty breathing or swallowing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear.

A bone problem called slipped capital femoral epiphysis. This happens when the top of the upper leg (femur) slips apart from the rest of the bone. Seek immediate medical attention if your child develops a limp or has hip or knee pain.

Worsened scoliosis (caused by rapid growth).

Injection site reactions including: swelling, loss of fat, increase of fat, pain, redness, or bruising. This can be avoided by changing/rotating the injection site at each injection.

Your child's doctor is your primary source of information about treatment. For more information, please talk to your doctor and download and review the full Patient Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For Patient Product Information, click here.